BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No

    Recall: Z-1978-2025 · Reported June 25, 2025

    Enforcement

    Recall Number
    Z-1978-2025
    Event ID
    96896
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Guangzhou Pluslife Biotech Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2025
    Initiation Date
    January 24, 2025
    Classification Date
    June 13, 2025
    Address
    Room 402, 6 Lianhuayan Road, Huangpu District, Guangzhou, N/A, N/A, China

    Description

    Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No

    Reason

    Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

    Code Info

    Model/Catalog Number: PM001; Lot numbers: All of the Devices in the U.S.

    Distribution

    Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Hong Kong, Australia, Singapore, Palestine, Russia, Ecuador, Papua New Guinea, Indonesia, South Africa, Zimbabwe, Brazil, Tunisia, Samoa, Algeria, Romania, Czech Republic, Thailand, South Korea, Malaysia, Fiji, Nepal, Peru, Mexico, Bahamas, Chile, India, Germany, France, Portugal, Vietnam, Spain, Poland, Latin American Region, Italy, Cameroon, Slovakia, Greece, Hungary Bahrain, Estonia, and Ukraine.

    Quantity

    541 units